Cynata Therapeutics (ASX:CYP) has reached a significant milestone in its lead osteoarthritis program, announcing the completion of all final participant visits in the Phase 3 SCUlpTOR trial evaluating its Cymerus-derived cell therapy, CYP-004, in knee osteoarthritis.
The final study visit marks the end of the two-year follow-up period for all participants enrolled in the University of Sydney–led trial. According to the company, data monitoring, quality-control checks, and complete analysis will now begin, with top-line results expected in the second quarter of 2026.
Cynata’s Chief Medical Officer, Dr Jolanta Airey, said the transition into the data-analysis phase represents a critical step for both the therapy and the company. “Completion of the follow-up of participants is a major milestone, which now sets in motion the final steps before the results of the trial are released in the coming months,” she said. “The trial is designed to determine if CYP-004 has a disease-modifying effect, in addition to relieving the symptoms of osteoarthritis. We are very much looking forward to the results.”
Osteoarthritis remains one of the world’s most significant chronic conditions, affecting around 600 million people globally and generating an economic burden exceeding US$468 billion annually in the United States alone. With no curative therapies available, patients typically progress from lifestyle interventions to anti-inflammatory medications and corticosteroid injections before many ultimately require joint replacement surgery.
CYP-004, a Cymerus-induced pluripotent stem cell (iPSC)-derived mesenchymal stromal cell product, is being developed as an off-the-shelf intra-articular therapy designed to reduce inflammation, relieve pain, and protect joint cartilage. The SCUlpTOR trial, a randomised, placebo-controlled Phase 3 study funded through an NHMRC project grant, is being led by osteoarthritis specialist Professor David Hunter, the Florance and Cope Chair of Rheumatology at the University of Sydney and Royal North Shore Hospital.